(Sr.) Regulatory Affairs Specialist

Core Accountabilities

• To obtain and maintain regulatory approval of product registration in Taiwan and work according to Good Regulatory Practice (GRP).
• To liaise with Emerging Market Regulatory Affairs (EMRA) and local Regulatory Authorities to ensure full regulatory compliance of the company.
• Develop and maintain effective working relationships with internal/external stakeholders to ensure achievement of best possible regulatory outcomes and meet business expectations.

Major Responsibilities

To obtain and maintain regulatory approval of product registration in Taiwan and work according to Good Regulatory Practice (GRP)

• To prepare all necessary documents to obtain regulatory approvals of Market Authorization in a timely manner.
• To maintain existing licenses (including license renewal, manufacturing site renewal, API GMP, CMC variations and prescribing text maintenance, etc.)
• To respond to Regulatory Authority’s questions within required timeline
• To upload all local regulatory documents and correspondence in AZ Global Electronic Library
• To submit the registration application in accordance with the agreed filing strategies and planning.
• To ensure regulatory activities comply with the company’s SOPs and meet GRP

To liaise with Emerging Market Regulatory Affairs (EMRA) and local Regulatory Authorities to ensure full regulatory compliance of the company

• To deliver local regulations to EMRA timely
• To develop competency to meet AstraZeneca standards

Requirement

• University education in bio/medical or pharmacy area
• Good command in English
• Background in pharmacy related field (desirable)

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.